Measuring Signs and Symptoms in Rheumatoid Arthritis Davi

1
Measuring Signs and Symptoms in Rheumatoid
Arthritis

• David R. Karp, MD, PhD
• Chief, Rheumatic Diseases
• UT Southwestern Medical Center

2
Clinical Research
Clinical Care
Billing Quality Assurance
3
Rheumatoid Arthritis

• Common autoimmune disease - Prevalence 1 of
  population
• Joint inflammation, swelling, pain, dysfunction,
  and disability
• Cartilage and bone destruction
• Significant co-morbidities

4
Diagnosis of RA

• Characteristic clinical features
• Presence of characteristic autoantibodies (but
  only in 80 of patients)
• Presence of characteristic radiographic findings
  (x-ray, MRI, or ultrasound)

5
(No Transcript)
6
(No Transcript)
7
(No Transcript)
8
Treatment of RA

• Synthetic Disease Modifying Anti-Rheumatic Drugs
• Methotrexate, leflunomide, sulfasalazine
• Biological agents (anti-cytokine)
• Anti-TNF, anti-B cell, anti-IL-6
• Combinations
• Placebo (in research)

9
Immunopathology of RA
Unaffected
Clinical
Pre-Clinical
Normal (?) Immune System
Auto-Antibodies Altered Cellular Immunity
Inflammation Tissue Damage Disability
Genetics - Environment
10
Why we Measure RA Determines How (Unfortunately)

• In the office
• Document to support a diagnosis and response to
  therapy
• (Usually) the minimum necessary to support a
  given level of billing - more detail more
• In research
• Standardized exams, lab tests, symptoms
• But, too many standards
• Efforts to use research standards in practice

11
Billable Interactions

• History (symptoms)
• Location, severity, timing, duration, quality,
  context, modifying factors, and associated signs
  and symptoms
• E.g., Complains of severe (9/10), aching pain in
  both hands and feet, worse in the morning,
  relieved with warm water, present daily for two
  weeks

12
Billable Interactions

• Physical Examination (signs)
• Vital Signs
• BP, pulse, respiration, temperature, height
• General appearance
• Inspection and palpation of the skin
• Examination of the bones, joints, muscles, and
  tendons for
• Alignment, tenderness, masses, effusions, etc.
• Range of motion
• Stability
• Strength

13
Billable Interactions

• Data (findings)
• Laboratory tests
• Rheumatoid factor, anti-citrullinated peptide
  antibodies
• Radiographs
• Joint space narrowing (loss of cartilage)
• Bony erosions
• Decision-making

14
Measuring RA in Research

• Pre-Clinical
• Auto-Antibodies (Rheumatoid Factor, anti-CCP,
  others)
• Genetics (HLA-DR4, others)
• Biomarkers, MRI
• Clinical
• Acute Phase Reactants (CRP, ESR)
• Tender/Swollen Joints
• Patient-Derived Measures (HAQ/Pain/Global)
• MD Impression
• Combined data
• Safety and co-morbidity

15
Measures of RA Activity or Response to Therapy

• ACR 20/50/70
• FDA mandated binary measure to differentiate
  placebo from active treatment
• Misses partial response
• May not be clinically meaningful
• DAS 28
• Empiric, continuous measure
• Can identify clinical remission
• Health Assessment Questionnaire

16
ACR 20/50/70

• 20 - 50 - 70 improvement in tender and swollen
  joint counts, and
• Indicated percent improvement in 3 of 5
• ESR or CRP
• Pain scale
• Patient global
• Physician global
• Health Assessment Questionnaire

17
DAS 28

• Tender Joints - 0-28
• Swollen Joints - 0-28
• ESR or CRP
• Global Health VAS (0-100)

18
Taking Research Metrics to the Clinic and Back

• Good evidence that tight control directed by
  standardized measures achieves a better
  functional outcome
• While DAS 28 works, other scales have been
  developed for real time assessment
• How much time does it take the patient,
  receptionist/RN, and physician?
• Consent/HIPAA
• Lack of EMR support
• Not (yet) required for billing or credentialling

19
(No Transcript)
20
How do you Monitor Response/Safety in Practice?

• FREQUENTLY DONE
• 96 Vital Signs
• 81 CBC, ESR
• 88 AM Stiffness
• 83 MD Overall assessment
• 75 Joint Exam (Pt focused)

• SELDOM DONE
• 27 28 Joint count TJC,SJC
• 20 66 Joint count
• 23 Yearly Feet X-rays
• 21 Yearly Chest Xray
• 21 Hepatitis panel
• 15 HAQ (some version)
• 16 Rheumatoid factor
• 12 CCP antibody
• 23 Urinalysis
• 5 MRI
• 1 Ultrasound
• 6 DAS (some version)
• 2.8 ACR20 (some version)

OFTEN DONE 68 CRP 59 PPD 54 LFTs 51
Yearly Hand X-rays 39,51 Pt Global, Pt Pain 39
Symptom survey 33 MD Global Assessment
21
Conclusions

• Rheumatology encounters are a combination of
  patient-, physician-, and test-derived
  information
• Data collected in real life for diagnosis and
  therapy, billing, and research may be different
• Likely drivers for standardized data collection
  will be EMR development, billing, and pay for
  performance issues (quality measures).